The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone.

Participants in the reference strategy group will undergo the eNO procedure but will follow NAEPP guidelines alone for asthma treatment without eNO measurements for the rest of the study.

Drug: Inhaled corticosteroids

Used for both regular asthma control and as a rescue inhaler

Experimental: Biomarker Strategy

Participants in the biomarker strategy group will follow NAEPP treatment guidelines, as well as eNO measurements, to determine asthma treatment at each study visit.

Drug: Inhaled corticosteroids

Used for both regular asthma control and as a rescue inhaler

Procedure: eNO measurement

measured by Aerocrine® NIOX device

Detailed Description:

Over the past two decades, the prevalence of asthma has dramatically increased in many parts of the world. The current National Asthma Education and Prevention Program (NAEPP) identifies inhaled corticosteroids (ICS) as the preferred long-term control therapy for all forms of persistent asthma. However, there is still a significant proportion of patients with persistent asthma who are not receiving ICS therapy or do not follow their treatment plan. Individualized asthma treatment plans are needed. The use of biomarkers, in addition to NAEPP guidelines, may help enhance the level of asthma assessment, guide medication regimens, and improve overall asthma control. This study will determine whether NAEPP-recommended treatment, combined with eNO measurement, is more effective in reducing asthma symptoms than NAEPP-recommended treatment alone. ICAC-01 will last 46 weeks and will comprise 8 study visits.

ICAC-01 also includes a mechanistic sub-study (ICAC-02). Its primary objective is to determine whether "highly sensitized", compared to "weakly sensitized" asthmatic subjects have more severe asthma, as defined by the levels at randomization to the completion of ICAC-01. To address the primary objective of ICAC-02, the study will include all the participants enrolled in ICAC-01 with dust mite-, cockroach- and/or alternaria-specific IgE levels within certain parameters.

Eligibility

Ages Eligible for Study:

12 Years to 20 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Clinical diagnosis of asthma made by a doctor over a year prior to study entry OR symptoms have been present more than a year if the diagnosis was made less than a year prior to study entry

Have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease. More information on this criterion can be found in the DAIT ICAC-01 protocol.

Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level

Do not smoke and have not used smokeless tobacco products in the year prior to study entry

Able to perform eNO measurement procedures and spirometry at study screening

Parent or guardian willing to provide informed consent, if applicable

History of clinical varicella (chicken pox) or have received varicella vaccine

Planning to stay in the area for the next 12 months

Primary language is English. Spanish speakers may enroll at centers with Spanish-speaking staff.

Parent or guardian primarily speaks English (or Spanish at centers with Spanish-speaking staff), for participants with parent or guardian providing informed consent

Willing to allow the study physician to manage disease for the duration of the study

Willing to change asthma medications in order to follow the protocol

Exclusion Criteria:

Adherence to controller medication between Visits 1 and 2 is less than 25%. More information on this criterion can be found in the DAIT ICAC-01 protocol.

Determined to have mild intermittent asthma at Visit 1

Have had a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure in the 5 years prior to study entry

Have significant medical illnesses other than asthma. More information on this criterion can be found in the DAIT ICAC-01 protocol.

Unable to use a metered-dose inhaler for administration of a beta-agonist rescue medication or a dry powder inhaler for the administration of asthma controller regimens

Known hypersensitivity to any medications commonly used for the treatment of asthma

Have not completed a home evaluation within 4 weeks of study screening

Currently participating in another asthma-related drug or intervention study, or have participated in another asthma-related drug or intervention study in the month prior to study entry

Does not sleep at least 4 nights per week in one home

Lives with a foster parent (not applicable if patient is able to provide informed consent)

Does not have access to a phone

Requires certain medications. More information on this criterion can be found in the DAIT ICAC-01 protocol.

Urine cotinine level above 100 ng/ml at study screening

Pregnant or breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114413